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Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking | Clinical Trials | Clareo Health

RECRUITING

Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

A Prospective, Multi-Center, Open-Label Clinical Investigation of the Cleaner Vac® Thrombectomy System for Treatment of Lower Extremity Proximal Deep Vein Thrombosis (DVT)

NCT07102160•Argon Medical Devices

View on ClinicalTrials.gov

Summary

The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the Cleaner Vac® Thrombectomy System for the treatment of thrombus in patients with lower extremity proximal deep vein thrombosis (DVT). This prospective, multi-center, open-label study will assess clinical outcomes, device performance, and procedural success in a single DVT study cohort.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet all the following criteria to be eligible for the study:
•1. At least 18 years of age at the time of consent.
•2. Undergo frontline (primary) treatment with Cleaner Vac® Thrombectomy System in the peripheral venous vasculature and have at least one component introduced into the body.
•3. Written informed consent obtained through the IRB-approved ICF.
•For the DVT cohort, participants must meet all criteria above and below to be eligible for the study:
•4. Present with unilateral or bilateral lower extremity DVT involving at least one of the following veins:
•1. Femoral-popliteal vein
•2. Common femoral vein
•3. Iliac vein
•4. Inferior Vena Cava (IVC)
+2 more criteria

Exclusion Criteria

•Subjects will be excluded from the study if any of the following criteria are met:
•1. Contraindication to systemic or therapeutic doses of anticoagulants.
•2. Contraindication to iodinated contrast that cannot be adequately premedicated.
•3. Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
•4. Patients that are pregnant.
•5. Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
•6. Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
•7. Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
•8. Known history of a Patent Foramen Ovale (PFO).
•9. Hemoglobin \< 8.0 g/dL, INR \> 2.0 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment.
+7 more criteria

Locations (3)

Baycare Health System

Tampa, Florida, United States

St. Elizabeth Healthcare - Edgewood

Edgewood, Kentucky, United States

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Key Dates

Start Date

February 4, 2026

Primary Completion Date

June 1, 2029

Completion Date

June 1, 2029

Last Updated

February 20, 2026

Enrollment

185

ESTIMATED participants

Conditions

Deep Vein Thrombosis (DVT)Thrombus in the Peripheral Venous VasculatureVenous EmbolismThrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts

Interventions

Aspiration thrombectomy system

DEVICE

Contacts

Esther Ajasa, MS

CONTACT

314-368-1219 Esther.ajasa@argonmedical.com

Danyel Carr, MS

CONTACT

469-731-1421 clinical@argonmedical.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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